Trial Master File (TMF) Operations Intern

JOB TITLE:

Trial Master File (TMF) Operations Intern

LOCATION:

Remote

DEPT NAME:

GCDO Business and Technology Capabilities

Brief Description:

The TMF Operations Intern (TOI) supports non-complex clinical trial and TMF activities in support of the GCDO Business & Technology Department. The TOI works closely with GCDO Business & Technology personnel to ensure department activities are conducted according to required activities and tasks delegated. As appropriate, they will identify issues and escalate to GCDO Business & Technology personnel. The core duties and responsibilities of the TOI are delineated below.

Essential Functions/Responsibilities

• General administrative support to the GCDO Business & Technology Department
• Manages eTMF content
• Perform Quality Control (QC) activities for TMF submissions in Jazz Clinical Vault (JV eTMF), in accordance with documented process
• Run eTMF metrics in Jazz Clinical Vault (JV eTMF), in accordance with documented process
• Assist in generating and managing trial dashboards for eTMF metrics
• General administrate support of GCDO Business & Technology department storage platforms (e.g., SharePoint, etc.)
• Assist in tracking of trial activities which may include but are not limited to study lists, QC review, FAQs, etc. 
• Routinely participates in department and/or clinical trial team meetings and participate in collaborative efforts (e.g., departmental initiatives, etc.)

Required Knowledge, Skills, and Abilities 

• Matriculated in a Bachelor’s degree program
• No industry experience required
• Exposure to in Good Clinical Practices (GCP) regulations and Standard Operating Procedures preferred
• Understanding of study phases and general knowledge of how they apply to clinical development is preferred
• Knowledge of Word, Excel, and PowerPoint and shared platforms (e.g., SharePoint, Box, Smartsheets)
• Strong verbal and written communication skills required